SAS ASO-Latex

GUDID 00780311000066

SAS™ ASO-Latex is a rapid latex agglutination test for the qualitative and semi-quantitative determination of Antistreptolysim O antibodies in serum.

SA SCIENTIFIC, LTD.

Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, agglutination, rapid

• Primary Device ID: 00780311000066
• NIH Device Record Key: f1d31352-8d4e-4611-8194-fb35d909994d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS ASO-Latex
• Version Model Number: 081100
• Company DUNS: 122092117
• Company Name: SA SCIENTIFIC, LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00780311000066 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-02

On-Brand Devices [SAS ASO-Latex]

• 00780311000073: 081050
• 00780311000066: SAS™ ASO-Latex is a rapid latex agglutination test for the qualitative and semi-quantitative d